Trends Over Time (1990-2010) of Diarrhoea-related Hospitalizations and Deaths in Children < 5 Years of Age in Brazil

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01175252
First received: August 3, 2010
Last updated: November 8, 2012
Last verified: November 2012
  Purpose

This study aims at collecting data to obtain baseline incidence and monitor trends over time in hospitalizations and deaths from all cause gastroenteritis in children <5 years of age, before and after implementation of Rotarix™ universal mass vaccination in Brazil.


Condition Intervention
Diarrhoea
Gastroenteritis
Other: Database analysis

Study Type: Observational
Study Design: Observational Model: Ecologic or Community
Time Perspective: Retrospective
Official Title: Time Trend Analysis of Diarrhea-related Hospitalizations and Deaths in Children < 5 Years of Age in Brazil, 1990-2010

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Occurrence of all cause gastroenteritis related hospital discharges and deaths [ Time Frame: In post vaccine introduction period compared to pre-vaccination period (gastroenteritis related hospital discharges from 1998 to 2010, gastroenteritis related deaths from 1990 to 2009) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Occurrence of all cause gastroenteritis related hospital discharges and hospital deaths by year, region and age groups [ Time Frame: From 1998 to 2010 ] [ Designated as safety issue: No ]
  • Occurrence of all cause gastroenteritis related deaths by year, region and age groups [ Time Frame: From 1990 to 2009 ] [ Designated as safety issue: No ]

Enrollment: 1
Study Start Date: December 2008
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Gastroenteritis Cohort
All children suffering with gastroenteritis
Other: Database analysis
Review and collect data from database

Detailed Description:

In this study baseline gastroenteritis related hospital discharges and mortality data from the Ministry of Health databases (DATASUS) will be compared to the current data after introduction of Rotarix™.

  Eligibility

Ages Eligible for Study:   up to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All children <5 years of age being hospitalized due to gastroenteritis between 1998 and 2010 and deceased due to gastroenteritis between 1990 and 2009 in Brazil.

Criteria

Inclusion Criteria:

  • Gastroenteritis associated hospital discharges and gastroenteritis related deaths occurring in children <5 years of age during the period analyzed and registered in the DATASUS databases will be collected for the study

Exclusion Criteria:

  • Not applicable
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01175252

Locations
Brazil
GSK Investigational Site
Belem, Pará, Brazil, 66 090 000
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Publications:
Lanzieri TM et al. (2010) Trends in hospitalizations from all-cause gastroenteritis in children <5 years of age in Brazil before and after human rotavirus vaccine introduction, 1998-2007. Pediatr Infect Dis J. 29(7):673-675.

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01175252     History of Changes
Other Study ID Numbers: 112368
Study First Received: August 3, 2010
Last Updated: November 8, 2012
Health Authority: Brazil: ANVISA

Keywords provided by GlaxoSmithKline:
Gastroenteritis

Additional relevant MeSH terms:
Diarrhea
Gastroenteritis
Signs and Symptoms, Digestive
Signs and Symptoms
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on April 17, 2014